This protocol applies to patients with nonmetastatic anal canal squamous cell carcinoma — confirmed absence of distant metastasis — who are able to tolerate mitomycin-based chemoradiotherapy. Concurrent chemoradiotherapy is the established primary treatment recommendation for this population, including patients with positive para-aortic lymph nodes that can be encompassed within the radiation field.
For patients with biopsy-proven locally progressive disease, a surgical approach may be indicated. In selected cases, immunotherapy may be considered as a preliminary intervention in an effort to avoid an operation — some patients may achieve a clinically meaningful response. The complete decision algorithm, including specific agent selection, sequencing criteria, and the full range of management options, is available in the full protocol.
DOI: 10.6004/jnccn.2023.0030
Currently, concurrent chemoRT is the recommended primary treatment of patients with nonmetastatic anal canal cancer as well as for patients with positive para-aortic lymph nodes that can be included in the radiation field, although only limited retrospective data support use in this setting.
Patients with biopsy-proven locally progressive disease are candidates for radical surgery with an APR and colostomy.
In an attempt to avoid surgery, the use of immunotherapy with nivolumab or pembrolizumab may be considered prior to APR (category 2B) as some patients may have a good response.
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